Blue Sky Bio · Class II · Cleared Aug 4, 2017
| K-number | K163251 |
| Device name | Life Essence Universal Porcelain System |
| Applicant | Blue Sky Bio |
| Product code | EIH |
| Device class | Class II |
| Decision date | Aug 4, 2017 |
| Decision | Substantially Equivalent |
| Regulation | 872.6660 |
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